The Directive 2001/83/EC as amended has been already introduced into low in every Member State. Before the directive was implemented the law of pharmaceutical drugs in every country was different causing several problems on the open market in EU therefore it was decided to harmonize legal provisions of the Member States. First at all this Directive says that medical product (excluding radiopharmaceuticals prepared at the time of use in approved health care) cannot be placed on the market of a Member State without prior authorization by the competent authority of the Member State in accordance with this directive and also this authorisation may be only issued to an applicant from a Community. Required documents and series of procedures during process of drug marketing authorisation are very strict controlled. These provisions can make some difficulties for an applicant to obtain drug marketing authorisation but they are to ensure an adequate standard, safety, quality and efficacy of the medical products available on the market. An application for authorization must be accompanied by a number of specific information and documents, in particular: • The name and composition of the medicinal product; • Description of production method; • Therapeutic indications, contraindications and side effects; • Dosage, application, route of administration of the medical product and expected shelf life ; • Safety precautions during storage and administration of the medicinal product; • Product waste disposal and potential risk to the environment caused by the medical product; • Control methods adopted by the manufacturer; • The pharmaceutical and preclinical test results and also clinical trials results; • Description of pharmacovigilance system; ... ... middle of paper ... ...). In other Member States the representative bodies are called differently but all must follow implemented into low Directive 2001/83/EC. This Directive is to harmonise law of medicinal products in all Member States in EU. The low has been implemented in order to control entering the market drugs and that do not fulfil requirements of quality, safety and efficacy and thereby to protect our customer rights and health. Directive 2001/83/EC plays important role in developed countries of EU where on the marker we could find drugs to cure almost everything and our demand for various kind of drugs to be more beautiful and healthier cause that we can belief in every promise that is written on them. Such directive guards ours access to bad, not effective and danger or fake drugs and ensure that the information about the drug benefits and risk are comprehensive and correct.
There are a number of methods EU legislation is formed for instance regulations, directives and decisions are three different types of EU legislation. I am going to briefly explain these three as the way they will be enforced are different.
Before a new medicine can be licensed for use in the UK, a long-lasting research (12 years) needs to be carried out. During this time each new medicine is assessed for its safety, quality and efficacy. A pharmaceutical company can apply for a marketing authorisation either through Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA). MHRA is an authority in the UK that is responsible for the safety of medicines and medical devices while EMA evaluates the use of medicinal products across all member states within the European Union.
U.S. Food and Drug Administration. (2014, April 16). Summary Basis for Regulatory Action - ALPROLIX. Retrieved May 19, 2014, from ALPROLIX: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm393432.htm
was approved in 1982 and in another form, that is to be taken orally rather than
...harmacyregulation.org. 2013. Revalidation | General Pharmaceutical Council. [online] Available at: http://pharmacyregulation.org/education/revalidation [Accessed: 25 Nov 2013].
Internationally there are different models of pharmacists prescribing. In the United Kingdom (UK), dependent prescribing (i.e. prescribing authorities through different protocols, formularies) by pharmacist was approved in 2003 and in 2006 Pharmacist got obtained independent prescribing right (i. e. prescribing personnel is solely responsible for the patient assessment, diagnosis and clinical managements) (Tonna, Stewart & McCaig, 2008). In contrast, all prescribing in Canada is independent and varies by provinces. Canadian pharmacist association reported i...
“About 150 million people in the US use dietary supplements; about 79% use it on a daily bases, and 10% taking 5 or more per day” (Ranjani 478). Dietary supplements range from sports performance products, weight loss products, to a variety of herbal remedies. These supplements are used widely to help maintain or improve the health of the human body. While buying these products many assume that they are regulated and are safe for human consumption, however it may not be the case. “Supplements face no FDA requirements for premarket testing. Supplements can be placed on the market at the will of the makers and then remain legal for sale” (Quinones 32). Dietary supplements should be regulated like prescription drugs because it’s a safety hazard, can become addictive, and may lead to dangerous health problems.
In current world the medical practitioners faces a lot of ethical dilemmas. According to ASHP foundation forecast, (2016-2020), the dilemmas are brought by technology advancements and shifting pharmaceutical marketplace dynamics. Thus seems there is the theory that explains tension between population healthcare and personal health care and overpricing of the medicine. This is due to lack transparency during the drug pricing decisions and though the united States have commenced investigations with the intentions to intervene, this problem does not seem to end in the near future. This overpricing may prevent all the patients getting the medicines. Pharmacists are also faced with the problem of reconciling advice and protocols on population-based with those on individual patients. Manufacturers and suppliers bear the responsibility to
Pharmacies in France are specialized facilities which work closely with clients, ensuring safe products and providing professional advice. Pharmaceutic...
Nadelmann, Ethan. "DRUGS: THINK AGAIN." European Coalition for Just and Effective Drug Policies. Sept.-Oct. 2007. Web. 02 Mar. 2011. .
Pharmacy is a booming field when it comes to medicine, but it certainly has controversial issues such as compounding drugs. While the practice of making drugs customized to a patient seems ethical, there are problems that come along with it. Drug compounding was the norm in the past, but over time consumers began to see issues with it. Drug compounding still occurs to this day because some patients do need medicine specifically tailored to their needs. Compounding has also been the focus of recent disasters, some of which occurred less than two years ago. Whatever side one may take on this issue, it is clear that compounding medicine will be a polarizing issue for years to come.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
The ability to become reflective in practice has become a necessary skill for health professionals. This is to ensure that health professionals are continuing with their daily learning and improving their practice. Reflective practice plays a big part in healthcare today and is becoming increasingly noticed.
According to Pires de Carvalho, a local working requirement, is against Article XX(j) of the GATT and the lack of sufficient domestic supply can be satisfied by importation. Nevertheless, Pires de Carvalho ignores the very important facts that transnational pharmaceutical companies may disregard small markets and pharmaceutical products are highly regulated by national health agencies. Sometimes deficient supply would possibly happen in certain areas as drugs are not as free as other goods and services flowing in the global market.
Pharmacovigilance is defined as study and surveillance of post marketed drugs. The importance of pharmacovigilance is to ensure the safety of drugs consumed by patients. So, why U.S. Food and Administration (FDA) still surveillance post marketed drug even though, these drugs go through such vigorous review, follow strict procedures and standards that are in compliance with GMP established by FDA during clinical trials and also goes through CDER. The Center of Drug Evaluation and Research (CDER) is a part of FDA that is responsible for the safety and effectiveness of all drugs ranging from prescription drugs to over-the-counter, which includes; shampoo, deodorant, sunscreens, vitamins etc. The way the research and investigation at CDER works is that, there are different departments for types of products. For example; generic drug, clinical review, biotechnology products or therapeutics products. Not only, CDER is responsible for safety and effectiveness of the drugs but they also provide information on how to use the drugs safely and effectively for both healthcare professional and co...